NDC 0955-2900-01 - Insulin glargine U-300

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0955-2900
Requested NDC
0955-2900-01
Package NDCs from labels
0955-2900-01, 0955-2900-02
Manufacturer
Sanofi-Aventis U.S. LLC | Genzyme Corporation | Sanofi-Aventis Deutschland GmbH
Effective date
2025-05-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Insulin glargine U-300 - Sanofi-Aventis U.S. LLC | Genzyme Corporation | Sanofi-Aventis Deutschland GmbHSanofi-Aventis U.S. LLC | Genzyme Corporation | Sanofi-Aventis Deutschland GmbH2025-05-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0955-2900-01Insulin glargine U-300 Max3 mL in 1 SYRINGEINJECTION, SOLUTION37
0955-2900-02Insulin glargine U-300 Max2 in 1 CARTONINJECTION, SOLUTION27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0955-2900INSULIN GLARGINE U-300 (INSULIN GLARGINE) INJECTION, SOLUTION INSULIN GLARGINE U-300 MAX (INSULIN GLARGINE) INJECTION, SOLUTION [WINTHROP U.S.]6Current NDC, 2 package rows20240913_99ea856d-9562-443a-9422-1006a3cff2f4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-2900-01ML - Milliliter0955-2900d5f1116f-3b0d-4a22-b902-789dc1133f5512024-02-14
0955-2900-02ML - Milliliter0955-29006dda0158-cc5b-4530-884a-73ea65000a7e12024-02-14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 36 of 36 · 718 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcneANTIMON. CRUD., ARSENICUM ALB., AUR. MET., BERBER. AQUI., BOVISTA, CARBO VEG., CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., HYDROCOTYLE, KALI BROM., KALI IOD., LEDUM, LYCOPODIUM, NUX VOM., SILICEA, SULPHUR IOD., ZINC. MET., ECHINACEA, JUGLANS REGIA, LAPPA, TARAXACUMNewton Laboratories, Inc.798d5f34-819a-9895-e053-2991aa0a1d622020-11-24WarningsExact identifier
unii: J41CSQ7QDS
ConstipationABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUMNewton Laboratories, Inc.90807700-3099-850c-e053-2995a90ada552020-11-24WarningsExact identifier
unii: J41CSQ7QDS
ConstipationABIES NIG., AESCULUS HIPP., ALOE, ALUMINA, BRYONIA, CARBO VEG., CHELIDONIUM MAJUS, COLLINSONIA , GRAPHITES, HYDRASTIS, KALI CARB., LYCOPODIUM, MAG. MUR., MEZEREUM, NUX VOM., PODOPH. PELT., RHAMNUS PURSHIANA, SANICULA, SELENIUM, SEPIA, SILICEA, TABACUM, VERATRUM ALB., ZINC.MET., ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA, TARAXACUMNewton Laboratories, Inc.90804a94-1e67-3ab3-e053-2a95a90aafbe2020-11-24WarningsExact identifier
unii: J41CSQ7QDS
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hangover ReliefASAFETIDA,CAPSICUM,POTASSIUM DICHROMATE,COLA NUT,LACHESIS MUTA VENOM,STRYCHNOS NUX-VOMICA SEED,RANUNCULUS BULBOSUS,SULFURIC ACID,ZINC.Homeocare Laboratories93b4a184-572c-48ef-9fc0-8e357a1e0d1b2018-12-18WarningsExact identifier
unii: J41CSQ7QDS
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Metabolic DetoxBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, SARSAPARILLA (SMILAX REGELII), GELSEMIUM SEMPERVIRENS, VERATRUM ALBUM, FERRUM METALLICUM, IODIUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PULSATILLA (VULGARIS), SELENIUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM METALLICUMHealthsource of New England LLCa4d0cb2d-a8c0-422a-a8fd-c8f92edcef442018-10-18WarningsExact identifier
unii: J41CSQ7QDS
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Free RadicalTRITICUM AESTIVUM, ALFALFA, FUCUS VESICULOSUS, LAMINARIA DIGITATA, NASTURTIUM AQUATICUM, ORYZA SATIVA, RAPHANUS SATIVUS, SYMPHYTUM OFFICINALE, HORDEUM VULGARE, ASPARAGUS OFFICINALIS, MANGANESE GLUCONATE, FERRUM PHOSPHORICUM, ARNICA MONTANA, CUPRUM METALLICUM, UBIDECARENONUM, ALPHA-KETOGLUTARICUM ACIDUM, GLYOXAL TRIMER DIHYDRATE, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUMBioActive Nutritional, Inc.e09f8fbb-e8c7-4c1b-994a-60f8fef79c0a2018-05-22WarningsExact identifier
unii: J41CSQ7QDS
Homeoplex AARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, ARSENICUM IODATUM, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMSupplement Clinic, LLC.fee279bf-76b7-4a84-ac8c-cd2489a910fb2017-11-01WarningsExact identifier
unii: J41CSQ7QDS
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: PDC6A3C0OX
Heavy Metal Detox T014ALLIUM SATIVUM, AVENA SATIVA, BERBERIS VULGARIS, LAPPA MAJOR, PHYTOLACCA DECANDRA, SOLIDAGO VIRGAUREA, LYCOPODIUM CLAVATUM, NUX VOMICA, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, CHROMIUM, COBALTUM METALLICUM, CUPRUM METALLICUM, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, EUROPIUM METALLICUM, FERRUM METALLICUMGuangzhou Renuma Medical Systems Co., Ltd41ce8009-71f2-418c-a38d-0cfaccfb74b42017-10-26WarningsExact identifier
unii: J41CSQ7QDS
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Diathesis V 1GINKGO BILOBA, PANCREAS (SUIS), SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, CYSTEINUM, ZINCUM METALLICUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, FUMARICUM ACIDUM, NATRUM OXALACETICUMBioActive Nutritional, Inc.58a16fcf-b05f-41a9-a580-41da6300ac7f2016-11-04WarningsExact identifier
unii: J41CSQ7QDS
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.